[18F]FTC-146 PET/MRI in Healthy Volunteers & in CRPS & Sciatica

Status Completed

Clinical Trial Summary

Chronic pain can result from injured or inflamed nerves, as occurs in people suffering from sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause of pain in these conditions, but the current diagnostic tools are limited in pinpointing the area of origin. Several studies have implicated involvement of sigma-1 receptors in the generation and perpetuation of chronic pain conditions, others are investigating anti sigma-1 receptor drugs for the treatment of chronic pain. Using the sigma-1 receptor (S1R) detector and experimental radiotracer [18F]FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI) scanner, the researchers may potentially identify the source of pain generation in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica. The ultimate goal is to assist in the optimization of pain treatment regimens using an [18F]FTC-146 PET/MRI scan.

The study is not designed to induce any physiological/pharmacological effect.

Clinical Trial Description

Participants are either pain free (control) or will be recruited based on established criteria for sciatica or CRPS. A signed consent will be obtained from willing participants.

For the PET/MRI scan, the participants will be injected with [18F]FTC-146 intravenously. After injection, simultaneous PET and MRI scans will be acquired using a hybrid PET/MRI scanner. Throughout scanning, participants will be monitored for blood pressure, temperature, heart rate and pulse oximetry. Participants will be asked to void their bladder as frequently as they can to reduce radiation exposure. Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report.

Evidence in the literature points strongly toward an involvement of S1 receptors in nervous system inflammation, which is known to be an important biologic disease/disorder mechanism for maintenance and perpetuation of chronic pain.

The main purpose of this research study is to image and identify activated pain pathways in human subjects using [18F]FTC-146 PET/MRI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02753101
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Early Phase 1
Start date	February 9, 2016
Completion date	February 16, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS and Sciatica

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms